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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
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Incluson Criteria

  1. Subject has benign uterine disease
  2. Subject needs total hysterectomy.
  3. Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).

Exclusion Criteria:

  1. suspicion of malignancy
  2. the need for simultaneous interventions such as prolapse repair
  3. uterine size greater than 18 weeks of gestation
  4. ongoing peritoneal dialysis
  5. 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

    First Posted
    March 2, 2015
    Last Updated
    March 11, 2015
    Sponsor
    The Catholic University of Korea
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    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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