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

NCT01552421 | Terminated DMC

• 1 other identifier: NOTES02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystolithiasis; Surgery; Pain

Keywords

Cholecystectomy; Natural Orifice Transluminal Endoscopic Surgery; Transvaginal cholecystectomy; Postoperative outcome

Outcome Measures

Primary Outcomes (1)

• Cumulated postoperative pain with visual analogue scale (VAS)

  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.

  72 hours

Secondary Outcomes (14)

• Postoperative fatigue

  72 hours

• Postoperative well-being

  72 hours

• Postoperative nausea

  72 hours

• Postoperative vomiting

  72 hours

• Postoperative analgesic and antiemetic consumption

  72 hours

Study Arms (2)

TV NOTES cholecystectomy

ACTIVE COMPARATOR

Participants randomized to TV NOTES cholecystectomy

Procedure: TV NOTES cholecystectomy

Laparoscopic cholecystectomy

NO INTERVENTION

Participants randomized to laparoscopic cholecystectomy

Interventions

TV NOTES cholecystectomy PROCEDURE

Transvaginal NOTES cholecystectomy

TV NOTES cholecystectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead
• University of Copenhagen: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator
• Bispebjerg Hospital: collaborator

Study Sites (1)

Departement of Surgical Gastroenterology, Gentofte Hospital

Gentofte Municipality, 2900 Hellerup, Denmark

Location

MeSH Terms

Conditions

Cholecystolithiasis; Pain

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Meller Donatsky, MD

  Department of Surgical Gastroenterology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 13, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

DK (1)