Bowel Function After Minimally Invasive Hysterectomy
Primary Purpose
Constipation
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol 3350
Sponsored by
About this trial
This is an interventional prevention trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
- Able to understand the consenting process and willing to participate in study
Exclusion Criteria:
- Planned laparotomy
- Emergent surgery
- Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
- Planned bowel surgery
- Presence of colostomy
- Inability to consent
- Medical problems as follows:
- CKD (Cr: > 1.2 mg/dL)
- IDDM
- Cardiac disease
- Gastric ulcers
- Difficulty swallowing or esophageal stricture
- Persistent nausea or vomiting
- Signs or symptoms of a small bowel obstruction
Sites / Locations
- University of Chicago MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Participants receiving pre-operative laxative
Participants not receiving pre-operative laxative
Arm Description
Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.
Participants will not be given any laxatives.
Outcomes
Primary Outcome Measures
Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score
Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score
Patient assessment of constipation quality of life (PAC-QOL) - PAC-Qol is a self-reported questionnaire, was used to measure the quality of life of patients.9 The validated PAC-QoL is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. The first three subscales are used to assess the patient dissatisfaction index, with an overall score ranging from 0 to 96 (where lower scores correspond to better quality of life). The satisfaction subscale includes four items with a global score ranging from 0 to 16, so that each patient's self-reported definitive outcome is defined as either poor (0-4), fairly good (5-8), good (9-12), or excellent (13-16).
Secondary Outcome Measures
Visual Analog Scale for Pain Management
Visual analog scale - The visual analog scale (VAS) is a measure of subjective pain intensity. It is a continuous scale comprised of a horizontal visual analog scale that is 100 mm in length. The subject will place a mark on the scale to indicate the intensity of her pain. 0 mm would be no pain, 100 mm would be the greatest imaginable pain. Any mark in between will be measured in mm to indicate degree of pain the subject is experiencing.
Pain medication consumption tracking by participant
Type of pain medication consumption will be collected for up to 7 days post-surgery.
Pain medication consumption tracking by participant
Dosages of pain medication consumption will be collected for up to 7 days post-surgery.
Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score
Wexner a commonly used scoring system, is designed to assess the prevalence and severity of constipation. It is based on pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; type of assistance including laxatives; digitations or enemas; number of unsuccessful attempts at evacuation in a 24-h period and duration of constipation). The CSS consists of seven items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A cutoff score of 15 suggests constipation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263896
Brief Title
Bowel Function After Minimally Invasive Hysterectomy
Official Title
Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic NSAID use and anatomic manipulation.
There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.
The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.
Detailed Description
Following enrollment subjects will be randomized into the intervention/treatment arm and control arm. All subjects will be asked to complete a baseline demographic form and three questionnaires (PAC-SYM, PAC- QOL, Wexner Constipation score). Additional demographic information will be obtained from chart review. This information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation.
Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.
Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).
At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Following enrollment subjects will be randomized into the intervention/treatment arm and control arm through a randomizing process in the investigator's database.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants receiving pre-operative laxative
Arm Type
Experimental
Arm Description
Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.
Arm Title
Participants not receiving pre-operative laxative
Arm Type
No Intervention
Arm Description
Participants will not be given any laxatives.
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol 3350
Other Intervention Name(s)
Miralax
Intervention Description
Participants will take 1 17g pack per day for 10 days preceding surgery.
Primary Outcome Measure Information:
Title
Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score
Description
Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Time Frame
From 10 days pre-operation to 7 days post-operation
Title
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score
Description
Patient assessment of constipation quality of life (PAC-QOL) - PAC-Qol is a self-reported questionnaire, was used to measure the quality of life of patients.9 The validated PAC-QoL is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. The first three subscales are used to assess the patient dissatisfaction index, with an overall score ranging from 0 to 96 (where lower scores correspond to better quality of life). The satisfaction subscale includes four items with a global score ranging from 0 to 16, so that each patient's self-reported definitive outcome is defined as either poor (0-4), fairly good (5-8), good (9-12), or excellent (13-16).
Time Frame
From 10 days pre-operation to 7 days post-operation
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain Management
Description
Visual analog scale - The visual analog scale (VAS) is a measure of subjective pain intensity. It is a continuous scale comprised of a horizontal visual analog scale that is 100 mm in length. The subject will place a mark on the scale to indicate the intensity of her pain. 0 mm would be no pain, 100 mm would be the greatest imaginable pain. Any mark in between will be measured in mm to indicate degree of pain the subject is experiencing.
Time Frame
Day of surgery to 7 days after surgery
Title
Pain medication consumption tracking by participant
Description
Type of pain medication consumption will be collected for up to 7 days post-surgery.
Time Frame
Day of surgery to 7 days after surgery
Title
Pain medication consumption tracking by participant
Description
Dosages of pain medication consumption will be collected for up to 7 days post-surgery.
Time Frame
Day of surgery to 7 days after surgery
Title
Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score
Description
Wexner a commonly used scoring system, is designed to assess the prevalence and severity of constipation. It is based on pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; type of assistance including laxatives; digitations or enemas; number of unsuccessful attempts at evacuation in a 24-h period and duration of constipation). The CSS consists of seven items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A cutoff score of 15 suggests constipation.
Time Frame
Prior to surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
Able to understand the consenting process and willing to participate in study
Exclusion Criteria:
Planned laparotomy
Emergent surgery
Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
Planned bowel surgery
Presence of colostomy
Inability to consent
Medical problems as follows:
CKD (Cr: > 1.2 mg/dL)
IDDM
Cardiac disease
Gastric ulcers
Difficulty swallowing or esophageal stricture
Persistent nausea or vomiting
Signs or symptoms of a small bowel obstruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Specialist 2
Phone
773-834-0171
Email
vdemart@uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dianne Glass, MD, PhD
Phone
773-702-6118
Email
dianneglass@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Glass, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianne Glass, MD, PhD
Phone
773-702-6118
Email
dianneglass@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Dianne Glass, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20207340
Citation
Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
Results Reference
background
PubMed Identifier
27500338
Citation
Edenfield AL, Siddiqui NY, Wu JM, Dieter AA, Garrett MA, Visco AG. Polyethylene Glycol 3350 and Docusate Sodium Compared With Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):543-9. doi: 10.1097/AOG.0000000000001565.
Results Reference
result
PubMed Identifier
7654638
Citation
Clarke A, Black N, Rowe P, Mott S, Howle K. Indications for and outcome of total abdominal hysterectomy for benign disease: a prospective cohort study. Br J Obstet Gynaecol. 1995 Aug;102(8):611-20. doi: 10.1111/j.1471-0528.1995.tb11398.x.
Results Reference
result
PubMed Identifier
19880839
Citation
Mythen MG. Postoperative gastrointestinal tract dysfunction: an overview of causes and management strategies. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S66-71. doi: 10.3949/ccjm.76.s4.11.
Results Reference
result
PubMed Identifier
11755892
Citation
Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001 Nov;182(5A Suppl):11S-18S. doi: 10.1016/s0002-9610(01)00782-6.
Results Reference
result
PubMed Identifier
30413866
Citation
Iwanoff C, Giannopoulos M, Salamon C. Follow-up postoperative calls to reduce common postoperative complaints among urogynecology patients. Int Urogynecol J. 2019 Oct;30(10):1667-1672. doi: 10.1007/s00192-018-3809-x. Epub 2018 Nov 9.
Results Reference
result
PubMed Identifier
20946445
Citation
Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.
Results Reference
result
PubMed Identifier
8305390
Citation
Spence-Jones C, Kamm MA, Henry MM, Hudson CN. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and urinary stress incontinence. Br J Obstet Gynaecol. 1994 Feb;101(2):147-52. doi: 10.1111/j.1471-0528.1994.tb13081.x.
Results Reference
result
PubMed Identifier
15902178
Citation
Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
Results Reference
result
PubMed Identifier
12172223
Citation
Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002 Jul;57(7):462-7. doi: 10.1097/00006254-200207000-00023.
Results Reference
result
PubMed Identifier
27310715
Citation
Hur HC, Lightfoot M, McMillin MG, Kho KA. Vaginal cuff dehiscence and evisceration: a review of the literature. Curr Opin Obstet Gynecol. 2016 Aug;28(4):297-303. doi: 10.1097/GCO.0000000000000294.
Results Reference
result
PubMed Identifier
22453316
Citation
McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529.
Results Reference
result
PubMed Identifier
25473191
Citation
Marciniak CM, Toledo S, Lee J, Jesselson M, Bateman J, Grover B, Tierny J. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial. World J Gastroenterol. 2014 Nov 21;20(43):16323-33. doi: 10.3748/wjg.v20.i43.16323.
Results Reference
result
PubMed Identifier
27404560
Citation
Iyigun E, Ayhan H, Demircapar A, Tastan S. Impact of preoperative defecation pattern on postoperative constipation for patients undergoing cardiac surgery. J Clin Nurs. 2017 Feb;26(3-4):495-501. doi: 10.1111/jocn.13473. Epub 2016 Aug 15.
Results Reference
result
PubMed Identifier
17403074
Citation
Dipalma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007 Jul;102(7):1436-41. doi: 10.1111/j.1572-0241.2007.01199.x. Epub 2007 Mar 31.
Results Reference
result
PubMed Identifier
28983926
Citation
Yiannakou Y, Tack J, Piessevaux H, Dubois D, Quigley EMM, Ke MY, Da Silva S, Joseph A, Kerstens R. The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1103-1111. doi: 10.1111/apt.14349. Epub 2017 Oct 6.
Results Reference
result
PubMed Identifier
10522604
Citation
Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
Results Reference
result
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Bowel Function After Minimally Invasive Hysterectomy
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