Needlescopic versus transvaginal/transumbilical cholecystectomy: a randomized clinical trial
Organizational Data
- DRKS-ID:
- DRKS00000341
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2010-02-24
- Last update in DRKS:
- 2017-08-11
- Registration type:
- Retrospective
Acronym/abbreviation of the study
NATCH
URL of the study
No Entry
Brief summary in lay language
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.
Brief summary in scientific language
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 we will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group we 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 we 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).
Health condition or problem studied
- ICD10:
- K80.20
- ICD10:
- K80.10
- Free text:
- 5-511.11: Laparoscopic cholecystectomy
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
- Arm 2:
- 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.
Endpoints
- Primary outcome:
- Intensity of pain in motion measured from operation day to postoperative day 2. This outcome includes a total of 4 measurements.
- Secondary outcome:
- Cosmetic aspects and overall satisfaction with the results of the surgery: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale. || Intraoperative complications, undesirable events, conversions. || 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 measured from postoperative day 2 to 10. This outcome includes a total of 17 measurements. || Use of analgesics: quantity, dose and class of the used drugs between the operative day and postoperative day 10. || Postoperative complications including frequency of reoperation. || Return to everyday, work related and free time activities: duration of limitations. || Quality of life measured on postoperative day 10 with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al. || Postoperative restrictions of sexual function: to be measured 3 months after surgery with part 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 before their operation, and again 10 to 14 days and 6 months after their surgery.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2010-02-19
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2013-01-04
- Target Sample Size:
- 40
- Final Sample Size:
- 40
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- Female gender; 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, choledocholithisis, 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 analagesics 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.
Addresses
Primary Sponsor
- Address:
- Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus MerheimOstmerheimerstr. 20051109 KölnGermany
- Telephone:
- 0221-8907-3770
- Fax:
- 0221-8907-8561
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kliniken-koeln.de/krankenhaeuser/KrankenhausMerheim/Viszeralchirurgie/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)Dr. med. Stefan SauerlandDillenburger Straße 2751105 KölnGermany
- Telephone:
- +49 (0)221 / 356 85 - 359
- Fax:
- +49 (0)221 / 356 85 - 873
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.iqwig.de
Contact for Public Queries
- Address:
- Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus MerheimDr. med. Dirk R. BulianOstmerheimerstr. 20051109 KölnGermany
- Telephone:
- 0221-8907-3770
- Fax:
- 0221-8907-8561
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kliniken-koeln.de/krankenhaeuser/KrankenhausMerheim/Viszeralchirurgie/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus MerheimOstmerheimerstr. 20051109 KölnGermany
- Telephone:
- 0221-8907-3770
- Fax:
- 0221-8907-8561
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kliniken-koeln.de/krankenhaeuser/KrankenhausMerheim/Viszeralchirurgie/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Witten/HerdeckeAlfred-Herrhausen-Str. 5058448 WittenGermany
- Telephone:
- +49-2302-926740
- Fax:
- +49-2302-926739
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2009-11-17
- Ethics committee number:
- 89/2009
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2010-01-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Transvaginal/Transumbilical Hybrid—NOTES—Versus 3-Trocar Needlescopic Cholecystectomy: Short-Term Results of a Randomized Clinical Trial
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry