The Effect of Transvaginal vs. Conventional Laparoscopic Cholecystectomy on the Postoperative Course (TRAVAKOL)

This study has been terminated.
(For logistic reasons in the department and due to very low inclusion rates.)
Sponsor:
Collaborators:
University of Copenhagen
University Hospital, Gentofte, Copenhagen
Bispebjerg Hospital
Information provided by (Responsible Party):
Anders Meller Donatsky, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01552421
First received: March 7, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to severe pain until the first postoperative day. This will subside during the second and third postoperative day [1]. A feeling of low general well-being will also be present until the first postoperative day and subside during the next couple of days [2].

To achieve faster recovery after laparoscopic interventions it has been shown that a reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative pain [3,4].

A new minimal invasive surgical technique is based on the principle of completely eliminating the use of ports through the abdominal wall. This new technique is called Natural Orifice Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal invasive access to the abdominal cavity through the body's natural openings like the mouth and stomach, anus, urethra and vagina. With the NOTES technique one can completely avoid incisions in the abdominal wall and thereby reduce the surgical trauma. The benefits of this technique is a reduction of postoperative pain, elimination of incisional hernias, prevention of wound infections, reduction of peritoneal adherence formation, achieving a faster recovery and a better cosmetic result [7,8].

The most documented and well-described way for gaining NOTES access to the abdominal cavity is through the vagina, transvaginal (TV). TV NOTES has mainly been used for cholecystectomy because of the direct line of vision to the upper abdomen and gallbladder that is achieved through this opening.

Compilation of results show that TV NOTES cholecystectomy can be implemented with low complication rates [20-22]. One retrospective case-control and one prospective observational study report less postoperative pain, reduced consumption of analgesics and faster recovery for TV NOTES compared to conventional laparoscopic cholecystectomy [23,24]. To date there are no systematic prospective randomized data on whether or not TV NOTES cholecystectomy leads to a better surgical outcome.

In the present study the postoperative course after TV NOTES cholecystectomy will be compared to laparoscopic cholecystectomy in a prospective randomized and blinded trial. The outcome of the randomization between the two surgical techniques will be blinded to patient and the nurse staff for the first 72 hours after the operation. The primary outcome parameter will be postoperative pain score during the first 24 hours. Secondary outcome parameters are postoperative pain score for the first 72 hours, fatigue, well-being, nausea, consumption of analgesics, complications, cosmetic result and sexual function.

The hypothesis being that TV NOTES cholecystectomy gives less postoperative pain, fatigue and nausea, a reduction in analgesics and a better cosmetic result and general well-being than conventional 4 port laparoscopic cholecystectomy.


Condition Intervention
Cholecystolithiasis
Surgery
Pain
Procedure: TV NOTES cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Transvaginal vs. Conventional Laparoscopic Cholecystectomy on the Postoperative Course

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Cumulated postoperative pain with visual analogue scale (VAS) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Postoperative pain will be measured with VAS, 3 hours after the operation as well as on the first, second and third postoperative day. Pain score will be assessed at rest and during mobilization from supine to erect posture. Based on these assesments a cumulated overall pain score for the first 72 postoperative hours will be calculated by adding the respective scores for each participant.


Secondary Outcome Measures:
  • Postoperative fatigue [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Postoperative fatigue will be measured on a scale from 0 (no fatigue) to 10 (severe fatigue) 3 hours post surgery and on postoperative day 1, 2 and 3.

  • Postoperative well-being [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Well-being will be measured with VAS 3 hours post surgery and on postoperative day 1, 2 and 3.

  • Postoperative nausea [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Nausea will be measured with VRS 3 hours post surgery and on postoperative day 1, 2 and 3.

  • Postoperative vomiting [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Total number of times the participant have been vomiting 3 hours post surgery and on postoperative day 1, 2 and 3.

  • Postoperative analgesic and antiemetic consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    All participants will be given oral Paracetamol 1g four times a day and Ibuprofen 400 mg three times a day for the first 72 postoperative hours. Any need for additional analgesics besides this will be registered. Consumption of antiemetics will be registered.

  • Postoperative complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Any postoperative complications will be registered during the participants admission and on follow-up 28 days (+/- 2 days) and 12 months (+/- 14 days) after surgery

  • Cosmetic result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Participants will be requested to score their satisfaction with the cosmetic result on a scale from 0 (no scarring) to 10 (severe scarring)28 days (+/- 2 days) and 12 months (+/- 14 days) after surgery.

  • Sexual function and dyspareunia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Participants are requested to fill in the questionnaire Female Sexual Function Index (FSFI) on sexual function and dyspareunia 28 days (+/- 2 days) and 12 months (+/- 14 days) after surgery.

  • Postoperative hospitalization [ Time Frame: Until the individual participant is discharged from the hospital ] [ Designated as safety issue: No ]
    The time from admission to discharge from the hospital is recorded.

  • Surgical details [ Time Frame: Intra-operative ] [ Designated as safety issue: Yes ]
    Details about the technical aspects of performing TV NOTES cholecystectomy is recorded during and immediate after surgery.

  • Early postoperative pain with VAS [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Early overall postoperative pain measured with VAS, 3 hours after the operation as well as on the first postoperative day. Pain score will be assessed at rest and during mobilization from supine to erect posture.

  • Late postoperative pain measured with VRS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Late postoperative pain measured with VRS on the second and third postoperative day. Pain score will be assessed at rest and during mobilization from supine to erect posture.

  • Early pain localization [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain localization (abdominal wall, intra-abdominal or shoulder pain) will be measured with VRS, 3 hours postoperatively as well as on the first postoperative day.

  • Late pain localization [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Pain localization (abdominal wall, intra-abdominal or shoulder pain) will be measured with VRS, on the second and third postoperative day.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TV NOTES cholecystectomy
Participants randomized to TV NOTES cholecystectomy
Procedure: TV NOTES cholecystectomy
Transvaginal NOTES cholecystectomy
No Intervention: Laparoscopic cholecystectomy
Participants randomized to laparoscopic cholecystectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Booked for cholecystectomy due to symptomatic gallstones or gallstone induced mild pancreatitis.
  • Woman.
  • Between 18 - 70 years old.
  • ASA classification I, II or III.
  • BMI < 30 kg/m2.
  • Written informed consent.

All of the inclusion criteria must be met before inclusion in the study.

Exclusion Criteria:

  • Expected poor compliance.
  • Previous cholecystitis or moderate to severe pancreatitis.
  • Culdotomy contraindicated.
  • Previous laparoscopic surgery or open surgery on vagina, uterus, fallopian tubes or ovaries. Except laparoscopic sterilisation.
  • Pregnancy or breastfeeding.
  • Daily consumption of any analgesic for one month prior to surgery or intermittent use of opioids.
  • Ongoing treatment with Monoamine Oxidase Inhibitors or Tricyclic antidepressants.
  • Known with any type of inflammatory bowel disease.
  • Known with chronic diseases that are known to cause pain sensations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552421

Locations
Denmark
Departement of Surgical Gastroenterology, Gentofte Hospital
Gentofte, Denmark, 2900 Hellerup
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
University Hospital, Gentofte, Copenhagen
Bispebjerg Hospital
Investigators
Principal Investigator: Anders Meller Donatsky, MD Department of Surgical Gastroenterology, Herlev Hospital
Study Chair: Lars Nannestad Jørgensen, MD, DSc, Prof. Department of Surgery K, Bispebjerg Hospital, University of Copenhagen
Study Chair: Sami Assaadzadeh, MD Department of Surgical Gastroenterology, Herlev Hospital
Study Chair: Jacob Rosenberg, MD, DSc, Prof. Department of Surgical Gastroenterology, Herlev Hospital, University of Copenhagen
Study Chair: Peter Vilmann, MD, DSc, Prof. Department of Surgical Gastroenterology, Herlev Hospital, University of Copenhagen
Study Chair: Søren Meisner, MD Department of surgery K, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Anders Meller Donatsky, MD, PhD-student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01552421     History of Changes
Other Study ID Numbers: NOTES02
Study First Received: March 7, 2012
Last Updated: September 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Cholecystectomy
Natural Orifice Transluminal Endoscopic Surgery
Transvaginal cholecystectomy
Postoperative outcome

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014