Calculus of Gallbladder With or Without CholecystitisNATCHNCT01685775
Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy
A study testing Transvaginal/transumbilical and Needlescopic with 3 trocars in people with Calculus of Gallbladder With or Without Cholecystitis and Laparoscopic Cholecystectomy, run by University of Witten/Herdecke at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Calculus of Gallbladder With or Without Cholecystitis, Laparoscopic Cholecystectomy
- What is being tested?
- Transvaginal/transumbilical and Needlescopic with 3 trocars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Abdominal, Vascular and Transplant Surgery; Cologne-Merheim Medical Center
Cologne, 51109
About this study
Official title: Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial
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.
Read the 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).
- Being tested
- Transvaginal/transumbilical, Needlescopic with 3 trocars
- Keywords
- Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal/transumbilicalProcedure or surgery
Needlescopic with 3 trocarsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal/transumbilical cholecystectomy | Experimental | 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 Receives: Procedure: Transvaginal/transumbilical |
| Needlescopic cholecystectomy | Active comparator | 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 Receives: Procedure: Needlescopic with 3 trocars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)
Measured: at the operation day
Intensity of pain in motion
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 1
Intensity of pain in motion
Pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 2
Secondary outcomes (22)
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
Measured: 10 days after operation
Intraoperative complications
e.g. bleeding, organ-injury, especially bile-duct-injury
Measured: evaluated at the operation day
Duration of the operation
(in minutes)
Measured: at the operation day
Surgical handling for the first and second surgeon
on a 1 to 5 scale
Measured: evaluated at the operation day
Intensity of pain in motion
in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 2
Cumulative use of analgesics
quantity, dose and class of the used drugs
Measured: 10 days after the surgery
Return to everyday, work related and free time activities
duration of limitations.
Measured: 3 months after operation
Quality of life
measured with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al.
Measured: on postoperative day 10
Postoperative restrictions of sexual function
with questions 14-19 of the "female sexual function index" (FSFI-D)
Measured: 3 months after surgery
Morphological consequences of transvaginal access
all patients from the transvaginal/transumbilical group will be examined by a gynaecologist
Measured: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
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
Measured: 3 months after operation
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
Measured: 6 months after operation
Conversionrate
Conversion from transvaginal to classical laparoscopic or open technique and from needlescopic to open technique
Measured: at the operation day
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
including frequency of reoperation
Measured: at 6 month
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 3
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 4
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 5
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 6
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 7
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 8
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 9
Intensity of pain in motion
in the morning and in the evening pain Scores on the Visual Analog Scale (0-10)
Measured: at postoperative day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Calculus of Gallbladder With or Without CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk R. Bulian, University of Witten/Herdecke
- Investigators
- Dirk R. Bulian, Principal investigator, Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685775
- Sponsor's protocol ID
- U1111-1114-7386
- Other IDs
- DRKS00000341
- Acronym
- NATCH
- Status last verified
- Oct 2013
- First submitted
- 4 Sep 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22926893Bulian 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.
PubMed 23456357Bulian 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.
PubMed 24108196
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01685775
- Acronym / sponsor ID
- NATCH / U1111-1114-7386
- Keywords
- Gallbladder, cholecystectomy, NOTES, natural orifice transluminal endoscopic surgery, gallstone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal/transumbilical cholecystectomy | Experimental | Procedure: Transvaginal/transumbilicalTransvaginal/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 | Active comparator | Procedure: Needlescopic with 3 trocarsNeedlescopic 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal/transumbilical | Procedure or surgery | Transvaginal/transumbilical cholecystectomy |
| Needlescopic with 3 trocars | Procedure or surgery | Needlescopic cholecystectomy |
Primary outcome
Intensity of pain in motion
Time frame: at the operation day
Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
Time frame: at postoperative day 1
2 measures (in the morning and in the evening) Pain Scores on the Visual Analog Scale (0-10)
Intensity of pain in motion
Time frame: at postoperative day 2
Pain Scores on the Visual Analog Scale (0-10)
22 secondary outcomes
Cosmetic aspects and overall satisfaction with the results of the surgery
Time frame: 10 days after operation
Intraoperative complications
Time frame: evaluated at the operation day
Duration of the operation
Time frame: at the operation day
Surgical handling for the first and second surgeon
Time frame: evaluated at the operation day
Intensity of pain in motion
Time frame: at postoperative day 2
Cumulative use of analgesics
Time frame: 10 days after the surgery
Return to everyday, work related and free time activities
Time frame: 3 months after operation
Quality of life
Time frame: on postoperative day 10
Postoperative restrictions of sexual function
Time frame: 3 months after surgery
Morphological consequences of transvaginal access
Time frame: at the day before the operation, and again 10 to 14 days and 6 months after their surgery
Cosmetic aspects and overall satisfaction with the results of the surgery
Time frame: 3 months after operation
Cosmetic aspects and overall satisfaction with the results of the surgery
Time frame: 6 months after operation
Conversionrate
Time frame: at the operation day
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: at 6 month
Intensity of pain in motion
Time frame: at postoperative day 3
Intensity of pain in motion
Time frame: at postoperative day 4
Intensity of pain in motion
Time frame: at postoperative day 5
Intensity of pain in motion
Time frame: at postoperative day 6
Intensity of pain in motion
Time frame: at postoperative day 7
Intensity of pain in motion
Time frame: at postoperative day 8
Intensity of pain in motion
Time frame: at postoperative day 9
Intensity of pain in motion
Time frame: at postoperative day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Background: PubMed 22926893Bulian 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.
- Background: PubMed 23456357Bulian 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 publication: PubMed 24108196Bulian 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk R. Bulian principal investigator
Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal/transumbilical and Needlescopic with 3 trocars in people with Calculus of Gallbladder With or Without Cholecystitis and Laparoscopic Cholecystectomy, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain in motion (time frame: at the operation day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.