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Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH)

Primary Purpose

Calculus of Gallbladder With or Without Cholecystitis, Laparoscopic Cholecystectomy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transvaginal/transumbilical
Needlescopic with 3 trocars
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calculus of Gallbladder With or Without Cholecystitis focused on measuring Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transvaginal/transumbilical cholecystectomy

Needlescopic cholecystectomy

Arm Description

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 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

Outcomes

Primary Outcome Measures

Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)

Secondary Outcome Measures

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
Intraoperative complications
e.g. bleeding, organ-injury, especially bile-duct-injury
Duration of the operation
(in minutes)
Surgical handling for the first and second surgeon
on a 1 to 5 scale
Intensity of pain in motion
in the evening pain Scores on the Visual Analog Scale (0-10)
Cumulative use of analgesics
quantity, dose and class of the used drugs
Return to everyday, work related and free time activities
duration of limitations.
Quality of life
measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
Postoperative restrictions of sexual function
with questions 14-19 of the "female sexual function index" (FSFI-D)
Morphological consequences of transvaginal access
all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
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
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
Conversionrate
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
including frequency of reoperation
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)

Full Information

First Posted
September 4, 2012
Last Updated
October 12, 2013
Sponsor
University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT01685775
Brief Title
Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy
Acronym
NATCH
Official Title
Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calculus of Gallbladder With or Without Cholecystitis, Laparoscopic Cholecystectomy
Keywords
Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk R. Bulian
Organizational Affiliation
Witten/Herdecke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center
City
Cologne
ZIP/Postal Code
51109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22926893
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.
Results Reference
background
PubMed Identifier
23456357
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.
Results Reference
background
PubMed Identifier
24108196
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.
Results Reference
result

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Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

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