Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

— NATCH  

Official title:

Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685775
• Other study ID #: U1111-1114-7386
• Secondary ID: DRKS00000341
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: October 12, 2013
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculus of Gallbladder With or Without Cholecystitis
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Laparoscopic Cholecystectomy

Intervention

Procedure:
• Transvaginal/transumbilical

• Needlescopic with 3 trocars

Locations

Country	Name	City	State
Germany	Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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/SL — View Citation

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. — View Citation

Bulian DR, Trump L, Knuth J, Siegel R, Sauerwald A, Ströhlein 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain in motion	Pain Scores on the Visual Analog Scale (0-10)	at the operation day	No
Primary	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	No
Primary	Intensity of pain in motion	Pain Scores on the Visual Analog Scale (0-10)	at postoperative day 2	No
Secondary	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	No
Secondary	Intraoperative complications	e.g. bleeding, organ-injury, especially bile-duct-injury	evaluated at the operation day	Yes
Secondary	Duration of the operation	(in minutes)	at the operation day	No
Secondary	Surgical handling for the first and second surgeon	on a 1 to 5 scale	evaluated at the operation day	No
Secondary	Intensity of pain in motion	in the evening pain Scores on the Visual Analog Scale (0-10)	at postoperative day 2	No
Secondary	Cumulative use of analgesics	quantity, dose and class of the used drugs	10 days after the surgery	No
Secondary	Return to everyday, work related and free time activities	duration of limitations.	3 months after operation	No
Secondary	Quality of life	measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.	on postoperative day 10	No
Secondary	Postoperative restrictions of sexual function	with questions 14-19 of the "female sexual function index" (FSFI-D)	3 months after surgery	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Conversionrate	Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique	at the operation day	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	including frequency of reoperation	at 6 month	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Trial document of the German Clinical Trials Register