Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

Not Applicable

Completed

• Conditions: Calculus of Gallbladder With or Without Cholecystitis; Laparoscopic Cholecystectomy
• Interventions: Procedure: Transvaginal/transumbilical; Procedure: Needlescopic with 3 trocars

• Registration Number: NCT01685775
• Lead Sponsor: University of Witten/Herdecke

Brief Summary

Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.

Detailed Description

The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecystectomy. The patients will be randomized on a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group the investigators will perform the Zornig technique using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault. The primary endpoint of this trial is to measure the intensity of pain in motion measured from the day of the operation until postoperative day 2. Four different measurements of pain will be used. Furthermore the investigators examine perioperative complications as security parameters. The trial is supported in part by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-07
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-14
• Study Completion: 2012-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-12
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Gender: Female
• Minimum Age: 18 Years
• Maximum Age: 80 Years
• indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
• age >=18 years and <=80 years
• legal competence

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Exclusion Criteria

• Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
• liver cirrhosis (Child Pugh A, B, C)
• severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
• intact hymen
• acute vaginal infection
• lacking visibility of the uterine orifice
• endometriosis
• malignoma
• obesity with a Body Mass Index (BMI) > 40 kg/m2
• chronic abuse of analgesics or alcohol
• neuromuscular disease that could interfere treatment or measures of pain
• history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
• gravidity or breastfeeding
• allergy against analgesics
• patients who are dependent on or employed by the trial sponsor or physicians
• institutionalisation for legal reasons
• participation in other clinical studies that could interfere with the present trial
• no written informed consent signed

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal/transumbilical cholecystectomy	Transvaginal/transumbilical	Transvaginal/transumbilical group: we will use a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault to perform the cholecystectomy in the Zornig style
Needlescopic cholecystectomy	Needlescopic with 3 trocars	Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder

Primary Outcome Measures

Name	Time	Method
Intensity of pain in motion	at postoperative day 2	Pain Scores on the Visual Analog Scale (0-10)

Secondary Outcome Measures

Name	Time	Method
Cumulative use of analgesics	10 days after the surgery	quantity, dose and class of the used drugs
Return to everyday, work related and free time activities	3 months after operation	duration of limitations.
Duration of the operation	at the operation day	(in minutes)
Cosmetic aspects and overall satisfaction with the results of the surgery	6 months after operation	1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view
Intraoperative complications	evaluated at the operation day	e.g. bleeding, organ-injury, especially bile-duct-injury
Surgical handling for the first and second surgeon	evaluated at the operation day	on a 1 to 5 scale
Intensity of pain in motion	at postoperative day 10	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Quality of life	on postoperative day 10	measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
Morphological consequences of transvaginal access	at the day before the operation, and again 10 to 14 days and 6 months after their surgery	all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
Postoperative restrictions of sexual function	3 months after surgery	with questions 14-19 of the "female sexual function index" (FSFI-D)
Conversionrate	at the operation day	Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	at 6 month	including frequency of reoperation

Trial Locations

Locations (1)

Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center; 🇩🇪 Cologne, Germany