Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

NCT ID: NCT01685775

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-12-31

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).

Conditions

Calculus of Gallbladder With or Without Cholecystitis; Laparoscopic Cholecystectomy

Keywords

Gallbladder; cholecystectomy; NOTES; natural orifice transluminal endoscopic surgery; gallstone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transvaginal/transumbilical

Intervention Type: PROCEDURE

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

Group Type: ACTIVE_COMPARATOR

Needlescopic with 3 trocars

Intervention Type: PROCEDURE

Interventions

Transvaginal/transumbilical

Intervention Type: PROCEDURE

Needlescopic with 3 trocars

Intervention Type: PROCEDURE

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Dirk R. Bulian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk R. Bulian

Role: PRINCIPAL_INVESTIGATOR

Witten/Herdecke University

Locations

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

Cologne, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22926893 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23456357 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24108196 (View on PubMed)

Other Identifiers

DRKS00000341

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1114-7386

Identifier Type: -

Identifier Source: org_study_id