Clinical trial NCT01685775: Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy
Official title: Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calculus of Gallbladder With or Without Cholecystitis
Laparoscopic Cholecystectomy
Keywords: Gallbladder
cholecystectomy
NOTES
natural orifice transluminal endoscopic surgery
gallstone
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
* 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

Primary outcomes:
measure: Intensity of pain in motion
timeFrame: at the operation day
measure: Intensity of pain in motion
timeFrame: at postoperative day 1
measure: Intensity of pain in motion
timeFrame: at postoperative day 2
Secondary outcomes:
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
timeFrame: 10 days after operation
measure: Intraoperative complications
timeFrame: evaluated at the operation day
measure: Duration of the operation
timeFrame: at the operation day
measure: Surgical handling for the first and second surgeon
timeFrame: evaluated at the operation day
measure: Intensity of pain in motion
timeFrame: at postoperative day 2
measure: Cumulative use of analgesics
timeFrame: 10 days after the surgery
measure: Return to everyday, work related and free time activities
timeFrame: 3 months after operation
measure: Quality of life
timeFrame: on postoperative day 10
measure: Postoperative restrictions of sexual function
timeFrame: 3 months after surgery
measure: Morphological consequences of transvaginal access
timeFrame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
timeFrame: 3 months after operation
measure: Cosmetic aspects and overall satisfaction with the results of the surgery
timeFrame: 6 months after operation
measure: Conversionrate
timeFrame: at the operation day
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: at 6 month
measure: Intensity of pain in motion
timeFrame: at postoperative day 3
measure: Intensity of pain in motion
timeFrame: at postoperative day 4
measure: Intensity of pain in motion
timeFrame: at postoperative day 5
measure: Intensity of pain in motion
timeFrame: at postoperative day 6
measure: Intensity of pain in motion
timeFrame: at postoperative day 7
measure: Intensity of pain in motion
timeFrame: at postoperative day 8
measure: Intensity of pain in motion
timeFrame: at postoperative day 9
measure: Intensity of pain in motion
timeFrame: at postoperative day 10
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center
Study officials:
affiliation: Witten/Herdecke University
name: Dirk R. Bulian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.