HysterectomyHOTNCT01830738
Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique
A study testing Single-port, peri-umbilical hysterectomy and Multi-port hysterectomy in people with Hysterectomy, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Single-port, peri-umbilical hysterectomy and Multi-port hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2014to Apr 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient is declared fit by the anesthetist for an intervention by laparoscopy
Who cannot join
- The patient is not available for 12 months of follow-up
- The patient is participating in another study or is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient is not insured or beneficiary of a health insurance plan
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
Show all 15Show fewer
- The patient cannot read French
- Patient with a history of pelvic radiotherapy
- Patient with a history of pelvic surgery or serious risk of major adhesions
- The patient is pregnant
- Contraindications for anesthesia for either surgical technique
- Promontofixation or lymphadenectomy
- No associated procedure other than morcellation or vaginal suture for extracting the hysterectomy specimen, unilateral or bilateral oophorectomy
- The patient has a known or suspected allergy to polyurethane
- Extended hysterectomy for neoplastic disease
Trial locations and contacts
3 sites in 1 country.
France3 sites
APHM - Hôpital de la Conception
Marseille, 13385
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
About this study
Official title: Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.
Read the detailed description
The secondary objectives are to compare the following between the two arms of the study:
- the difference between the real discharge date and the theoretical discharge date
- measures related to intraoperative bleeding
- operating time
- postoperative pain
- quality of life
- abdominal wall complication rates
- rates of further surgery and rehospitalization
- use of material resources in the operating room
- average costs of hospital stay
- Costs of rehospitalization at 1 year
- Indirect costs
- Conditions
- Hysterectomy
- Being tested
- Single-port, peri-umbilical hysterectomy, Multi-port hysterectomy
- Keywords
- laparoscopy, hysterectomy, single-port trocar, surgical technique, trocar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port, peri-umbilical hysterectomyProcedure or surgery
Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
Multi-port hysterectomyProcedure or surgery
Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| Peri-umbilical single-port | Experimental | Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
Intervention: Single-port, peri-umbilical hysterectomy Receives: Procedure: Single-port, peri-umbilical hysterectomy |
| Multi-port | Active comparator | Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.
Intervention: Multi-port hysterectomy Receives: Procedure: Multi-port hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay in hours
Measured: Maximum 1 month (usually 3 to 5 days)
Secondary outcomes (21)
Difference in hours between real discharge time and theoretical discharge time
Criteria for theoretical hospital discharge:
- Visual analog scale for pain < 2 under stage 1 antalgics
- No nausea, no vomiting
- Resumption of transit, liquid and solid food
- Capable of getting up, moving and going to the bathroom alone
- Apyrexia
Measured: 4 weeks
Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids
Measured: Day 0 (during surgery)
Change in hemoglobin measure
Measured: Day 3 versus baseline
Change in hematocrit measure
Measured: Day 3 versus baseline
Surgical time, from first incision to closing
Measured: Day 0 (during surgery)
Visual analog scale for pain
Measured: 2 hours after end of surgery (Day 0)
Visual analog scale for pain
Measured: 3 times per day during hospitalisation (expected maximum of 3 to 5 days)
Questionnaire SF 36
Quality of Life
Measured: baseline
Questionnaire SF 36
Quality of Life
Measured: 4 weeks
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Measured: Day 1
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Measured: 4 weeks
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Measured: 12 months
Re-intervention/hospitalisation rate
Measured: 12 months
Surgical conversion rate
Measured: Day 0 (during surgery)
Trocar site infection rate
Measured: 4 weeks
Presence/absence of complications according to Clavien scale
Measured: Day 1
Presence/absence of complications according to Clavien scale
Measured: 12 months
Inventory of reusable material in the operating room and related costs.
Measured: Day 0 (after surgery)
Estimatin of indirect costs
Measured: 4 weeks
Estimation of direct costs
Measured: 12 months
Questionnaire SF 36
Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionApr 2015
Why it stopped: Inclusion curve too poor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830738
- Sponsor's protocol ID
- LOCAL/2012/VL-03
- Other IDs
- 2012-A01054-36
- Acronym
- HOT
- Status last verified
- Oct 2015
- First submitted
- 10 Apr 2013
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay
- ClinicalTrials.gov ID
- NCT01830738
- Acronym / sponsor ID
- HOT / LOCAL/2012/VL-03
- Conditions
- Hysterectomy
- Keywords
- laparoscopy, hysterectomy, single-port trocar, surgical technique, trocar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion curve too poor.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Apr 2013 (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.
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.
Detailed description
The secondary objectives are to compare the following between the two arms of the study:
- the difference between the real discharge date and the theoretical discharge date
- measures related to intraoperative bleeding
- operating time
- postoperative pain
- quality of life
- abdominal wall complication rates
- rates of further surgery and rehospitalization
- use of material resources in the operating room
- average costs of hospital stay
- Costs of rehospitalization at 1 year
- Indirect costs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-umbilical single-port | Experimental | Procedure: Single-port, peri-umbilical hysterectomyPatients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. Intervention: Single-port, peri-umbilical hysterectomy |
| Multi-port | Active comparator | Procedure: Multi-port hysterectomyPatients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. Intervention: Multi-port hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient is declared fit by the anesthetist for an intervention by laparoscopy
Key exclusion criteria (15 listed)
- The patient is not available for 12 months of follow-up
- The patient is participating in another study or is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient is not insured or beneficiary of a health insurance plan
- The patient refuses to sign the consent
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 |
|---|---|---|
| Single-port, peri-umbilical hysterectomyPatients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. | Procedure or surgery | Peri-umbilical single-port |
| Multi-port hysterectomyPatients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. | Procedure or surgery | Multi-port |
Primary outcome
Length of hospital stay in hours
Time frame: Maximum 1 month (usually 3 to 5 days)
21 secondary outcomes
Difference in hours between real discharge time and theoretical discharge time
Time frame: 4 weeks
Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids
Time frame: Day 0 (during surgery)
Change in hemoglobin measure
Time frame: Day 3 versus baseline
Change in hematocrit measure
Time frame: Day 3 versus baseline
Surgical time, from first incision to closing
Time frame: Day 0 (during surgery)
Visual analog scale for pain
Time frame: 2 hours after end of surgery (Day 0)
Visual analog scale for pain
Time frame: 3 times per day during hospitalisation (expected maximum of 3 to 5 days)
Questionnaire SF 36
Time frame: baseline
Questionnaire SF 36
Time frame: 4 weeks
Complication rate
Time frame: Day 1
Complication rate
Time frame: 4 weeks
Complication rate
Time frame: 12 months
Re-intervention/hospitalisation rate
Time frame: 12 months
Surgical conversion rate
Time frame: Day 0 (during surgery)
Trocar site infection rate
Time frame: 4 weeks
Presence/absence of complications according to Clavien scale
Time frame: Day 1
Presence/absence of complications according to Clavien scale
Time frame: 12 months
Inventory of reusable material in the operating room and related costs.
Time frame: Day 0 (after surgery)
Estimatin of indirect costs
Time frame: 4 weeks
Estimation of direct costs
Time frame: 12 months
Questionnaire SF 36
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Inclusion curve too poor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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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.
Vincent Letouzey, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port, peri-umbilical hysterectomy and Multi-port hysterectomy in people with Hysterectomy, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 was stopped early (reason given: Inclusion curve too poor.). Results are not available in the source record.
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?
Length of hospital stay in hours (time frame: Maximum 1 month (usually 3 to 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2015.