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

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

Interventions

PROCEDURE

TV NOTES cholecystectomy

Transvaginal NOTES cholecystectomy

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• University Hospital, Gentofte, Copenhagen

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herlev Hospital

  lead OTHER

Principal Investigators

• Anders Meller Donatsky, MD · Department of Surgical Gastroenterology, Herlev Hospital

• Lars Nannestad Jørgensen, MD, DSc, Prof. · Department of Surgery K, Bispebjerg Hospital, University of Copenhagen

• Sami Assaadzadeh, MD · Department of Surgical Gastroenterology, Herlev Hospital

• Jacob Rosenberg, MD, DSc, Prof. · Department of Surgical Gastroenterology, Herlev Hospital, University of Copenhagen

• Peter Vilmann, MD, DSc, Prof. · Department of Surgical Gastroenterology, Herlev Hospital, University of Copenhagen

• Søren Meisner, MD · Department of surgery K, Bispebjerg Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2013-12-31

Completion

2014-12-31

Countries

• Denmark

Study Locations