Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy
Primary Purpose
Uterine Disease, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single-port laparoscopic hysterectomy(single port trochar)
multi-port laparoscopic hysterectomy(multi port trochar)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Disease focused on measuring postoperative pain, hysterectomy, single-port access laparoscopy, multi-port access laparoscopy, TLH
Eligibility Criteria
Incluson Criteria
- Subject has benign uterine disease
- Subject needs total hysterectomy.
- Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).
Exclusion Criteria:
- suspicion of malignancy
- the need for simultaneous interventions such as prolapse repair
- uterine size greater than 18 weeks of gestation
- ongoing peritoneal dialysis
- diseases associated with abdominal pain such as pancreatitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single-port laparoscopic hysterectomy
multi-port laparoscopic hysterectomy
Arm Description
total laparoscopic hysterectomy via transumbilical single port
total laparoscopic hysterectomy via multi-port (3 port)
Outcomes
Primary Outcome Measures
postoperative pain (Pain scores) intensity measure
self reported pain intensity measure for 2 days after surgery
Secondary Outcome Measures
Number of Participants with Adverse events
perioperative adverse event including bowel, bladder injury and severe hemorrahge
Full Information
NCT ID
NCT02390804
First Posted
March 2, 2015
Last Updated
March 11, 2015
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02390804
Brief Title
Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy
Official Title
Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Transumbilical Single-port Access and Conventional Three-port Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.
Detailed Description
The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Disease, Postoperative Pain
Keywords
postoperative pain, hysterectomy, single-port access laparoscopy, multi-port access laparoscopy, TLH
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-port laparoscopic hysterectomy
Arm Type
Experimental
Arm Description
total laparoscopic hysterectomy via transumbilical single port
Arm Title
multi-port laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
total laparoscopic hysterectomy via multi-port (3 port)
Intervention Type
Device
Intervention Name(s)
single-port laparoscopic hysterectomy(single port trochar)
Intervention Description
perform laparoscopic hysterectomy via single-port access
Intervention Type
Device
Intervention Name(s)
multi-port laparoscopic hysterectomy(multi port trochar)
Intervention Description
perform laparoscopic hysterectomy via multi-port access
Primary Outcome Measure Information:
Title
postoperative pain (Pain scores) intensity measure
Description
self reported pain intensity measure for 2 days after surgery
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse events
Description
perioperative adverse event including bowel, bladder injury and severe hemorrahge
Time Frame
up to 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Incluson Criteria
Subject has benign uterine disease
Subject needs total hysterectomy.
Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).
Exclusion Criteria:
suspicion of malignancy
the need for simultaneous interventions such as prolapse repair
uterine size greater than 18 weeks of gestation
ongoing peritoneal dialysis
diseases associated with abdominal pain such as pancreatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Hyun Chung, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19487164
Citation
Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.
Results Reference
background
PubMed Identifier
20035346
Citation
Jung YW, Kim YT, Lee DW, Hwang YI, Nam EJ, Kim JH, Kim SW. The feasibility of scarless single-port transumbilical total laparoscopic hysterectomy: initial clinical experience. Surg Endosc. 2010 Jul;24(7):1686-92. doi: 10.1007/s00464-009-0830-7. Epub 2009 Dec 25.
Results Reference
background
PubMed Identifier
19789919
Citation
Ng PC. Re: Surg Endosc (2009) 23:1142-1145, DOI:10.1007/s00464-009-0382-x (published online 5 March 2009). Erica P. Podolsky, Steven J. Rottman, Paul G. Curcillo II. Single Port Access (SPA) gastrostomy tube in patients unable to receive percutaneous endoscopic gastrostomy placement. Surg Endosc. 2010 Apr;24(4):970. doi: 10.1007/s00464-009-0705-y. No abstract available.
Results Reference
background
PubMed Identifier
21565338
Citation
Fagotti A, Bottoni C, Vizzielli G, Gueli Alletti S, Scambia G, Marana E, Fanfani F. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril. 2011 Jul;96(1):255-259.e2. doi: 10.1016/j.fertnstert.2011.04.006. Epub 2011 May 11.
Results Reference
background
PubMed Identifier
23860211
Citation
Song T, Kim ML, Jung YW, Yoon BS, Joo WD, Seong SJ. Laparoendoscopic single-site versus conventional laparoscopic gynecologic surgery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2013 Oct;209(4):317.e1-9. doi: 10.1016/j.ajog.2013.07.004. Epub 2013 Jul 13.
Results Reference
background
PubMed Identifier
24083850
Citation
Eom JM, Choi JS, Choi WJ, Kim YH, Lee JH. Does single-port laparoscopic surgery reduce postoperative pain in women with benign gynecologic disease? J Laparoendosc Adv Surg Tech A. 2013 Dec;23(12):999-1005. doi: 10.1089/lap.2013.0184. Epub 2013 Oct 1.
Results Reference
background
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Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy
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