Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH)

Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 51109
    • Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transvaginal/transumbilical cholecystectomy; 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	Procedure: Transvaginal/transumbilical
Active Comparator: Needlescopic cholecystectomy; 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	Procedure: Needlescopic with 3 trocars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain in motion	Pain Scores on the Visual Analog Scale (0-10)	at the operation day
Intensity of pain in motion	2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)	at postoperative day 1
Intensity of pain in motion	Pain Scores on the Visual Analog Scale (0-10)	at postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic aspects and overall satisfaction with the results of the surgery	1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view	10 days after operation
Intraoperative complications	e.g. bleeding, organ-injury, especially bile-duct-injury	evaluated at the operation day
Duration of the operation	(in minutes)	at the operation day
Surgical handling for the first and second surgeon	on a 1 to 5 scale	evaluated at the operation day
Intensity of pain in motion	in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 2
Cumulative use of analgesics	quantity, dose and class of the used drugs	10 days after the surgery
Return to everyday, work related and free time activities	duration of limitations.	3 months after operation
Quality of life	measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.	on postoperative day 10
Postoperative restrictions of sexual function	with questions 14-19 of the "female sexual function index" (FSFI-D)	3 months after surgery
Morphological consequences of transvaginal access	all patients from the transvaginal/transumbilical group will be examined by a gynaecologist	at the day before the operation, and again 10 to 14 days and 6 months after their surgery
Cosmetic aspects and overall satisfaction with the results of the surgery	1 (complete satisfaction) to 5 (complete dissatisfaction) scale from patient's and surgeon's point of view	3 months after operation
Cosmetic aspects and overall satisfaction with the results of the surgery	1 (complete satisfaction) to 5 (complete dissatisfaction) scale; from patient's and surgeon's point of view	6 months after operation
Conversionrate	Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique	at the operation day
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	including frequency of reoperation	at 6 month
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 3
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 4
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 5
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 6
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 7
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 8
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 9
Intensity of pain in motion	in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 10

Collaborators and Investigators

• Sponsor: University of Witten/Herdecke
• Investigators: Principal Investigator: Dirk R. Bulian, Witten/Herdecke University

Publications and helpful links

General Publications

• Bulian DR, Trump L, Knuth J, Siegel R, Sauerwald A, Strohlein MA, Heiss MM. Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc. 2013 Feb;27(2):580-6. doi: 10.1007/s00464-012-2490-2. Epub 2012 Aug 28.
• Bulian DR, Trump L, Knuth J, Cerasani N, Heiss MM. Long-term results of transvaginal/transumbilical versus classical laparoscopic cholecystectomy--an analysis of 88 patients. Langenbecks Arch Surg. 2013 Apr;398(4):571-9. doi: 10.1007/s00423-013-1071-8. Epub 2013 Mar 1.
• Bulian DR, Knuth J, Cerasani N, Sauerwald A, Lefering R, Heiss MM. Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial. Ann Surg. 2015 Mar;261(3):451-8. doi: 10.1097/SLA.0000000000000218.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 12, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: cholecystectomy; Gallbladder; NOTES; natural orifice transluminal endoscopic surgery; gallstone
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: U1111-1114-7386; DRKS00000341 (Registry Identifier: DRKS-ID)