Vaginal Cuff DehiscenceNCT03898726
Laparoscopic Versus Transvaginal Cuff Closure
A study testing laparoscopical l cuff closure in people with Vaginal Cuff Dehiscence and Vaginal Hematoma, run by El-Galaa Military Medical Complex at 1 site in Egypt.
Trial summary
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications . This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Vaginal Cuff Dehiscence, Vaginal Hematoma, Vaginal Infection
- What is being tested?
- laparoscopical l cuff closure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2018to 16 May 2019
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidate for total laparoscopic hysterectomy :
- Uterine size <12 weeks.
- Having no severe endometriosis.
- Having descent of no more than 1st degree of uterus.
- Non-malignant conditions.
- Completion of the entire procedure by laparoscopic approach up to colpotomy.
- Benign conditions as indications for hysterectomy.
Who cannot join
- 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.
- 4) Inability to express adequate informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications .
This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .
Read the detailed description
All the women will subject to:
Preoperative Assessment including:
- Detailed history taking including age ,parity, medical ,surgical history .
- Physical examination:
- General examination including the body mass index .
- Abdominal examination including presence of previous scars, uterine size , any tenderness and presence of palpable masses .
- Pelvic examination: including uterine size, any adnexal mass and tenderness .
- Preoperative investigation:
- A preoperative trans-vaginal ultra- sonography to assess the volume of the uterus, gross uterine pathology and any adnexal pathology.
- The preoperative laboratory investigation: hemoglobin percent and haematocrit value, blood grouping ,liver and kidney function tests.
Availability of blood was ensured for each patient before surgery.
Anaesthesia:
Standardized general anaesthetic technique consisting of induction agent, muscle-relaxant and inhalational agents with basic minimum monitoring after a detailed pre-anaesthetic check-up and adequate premedication advice.
Intraoperative :
- For vaginal cuff closure both in laparoscopic approach and vaginal route, the investigators will use the horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, and will continue toward the surgeon , using a continuous Vicryl suture .
- In the laparoscopic approach, needles will be introduced through one trocar and removed through the opposite trocars using a needle holders.
Postoperative care:
- The patient will receive IV fluids in the first 24hours (3litres).
- Oral clear fluid intake will be started 8 hours after the operation.
- Another dose of antibiotics will be received 6hrs after the operation with the same regimen used in induction.
- Postoperative analgesia will be received in the form of parental NSAIDs every 8hrs for 24hrs then on demand.
- The urinary catheter and the vaginal pack will be removed 24hrs after the operation , no drains will be left intraoperative.
- CBC will be done 24hrs after the operation.
- Histopathological examination of the specimen will be done.
- Precocious resumption of coital activity ,( all patients will be recommended to avoid vaginal intercourse for at least 2 months ) .
Follow Up:
- Transvaginal ultrasound will be done to all patients in the second day to Spot vaginal cuff hematoma if found .
- Women will be discharged on antibiotic ( third generation cephalosporins ) and analgesics ( NSAIDs ) and a follow-up visit will be scheduled after 7 days for a full examination to exclude vaginal cuff infection ( purulent drainage from the vaginal cuff on gross anatomic exam according to CDC ) or cuff hematoma (Any blood collection at the level of vaginal vault detected by transvaginal ultrasound).
- All women will be followed up after 3 months for the occurrence of vaginal cuff dehiscence (separation of a vaginal incision that was previously closed at time of initial hysterectomy) , at that time all women will undergo abdominal examination and bimanual pelvic examination for vaginal masses.
- All women will be asked for dyspareunia according to Marinoff scale: 0= no pain with intercourse .
- pain with intercourse that doesn't prevent the completion .
- pain with intercourse requiring interruption or discontinuance .
- pain with intercourse preventing any intercourse .
- Ethical Considerations:
- Patient information and informed consent:
Before being admitted to the clinical study, the patient must consent to participate after the nature, scope and possible consequences of the clinical study have been explained in a form understandable to her.
Protocol approval:
Before the beginning of the study and in accordance with the local regulation followed, the protocol and all the corresponding documents will be declared for Ethical and Research approval by the council of the OB/GYN department, Ain Shams University.
Assessment of the outcomes:
Primary outcomes:
- Vaginal cuff dehiscence: Any separation at the level of the vaginal vault.
Secondary outcomes:
- Vaginal cuff hematoma: Any blood collection at the level of vaginal vault detected by transvaginal ultrasound.
- Post operative pelvic infections: Any postoperative infection with signs and symptoms of vaginal cuff involvement including granulation formation .
- Operative time: Time spent in suturing the vaginal cuff transvaginally versus laparoscopically .
- Incidence of dyspareunia : according to Marinoff scale .
- Conditions
- Vaginal Cuff Dehiscence, Vaginal Hematoma, Vaginal Infection
- Being tested
- laparoscopical l cuff closure
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopical l cuff closureBiological
Also called transvaginal cuff closure
closure of vaginal cuff following hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopical l cuff closure | Active comparator | needle holder laparoscopic vaginal cuff closure Receives: Biological: laparoscopical l cuff closure |
| transvaginal cuff closure | Active comparator | transvaginal cuff closure Receives: Biological: laparoscopical l cuff closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. number of cases ofVaginal cuff dehiscence
Any separation at the level of the vaginal vault.
Measured: 3 months
Secondary outcomes (2)
number of cases with vaginal hematoma
ultrasound finding
Measured: 3 months
number of cases with vaginal infection
purulent vaginal discharge
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start27 Mar 2018
- Primary completion19 Apr 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Cuff DehiscenceStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- El-Galaa Military Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, amr saad mahmoud, El-Galaa Military Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898726
- Sponsor's protocol ID
- ElGalaa
- Status last verified
- Dec 2021
- First submitted
- 21 Mar 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT03898726
- Acronym / sponsor ID
- ElGalaa
- Conditions
- Vaginal Cuff Dehiscence, Vaginal Hematoma, Vaginal Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- El-Galaa Military Medical ComplexOther government
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications .
This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .
Detailed description
All the women will subject to:
Preoperative Assessment including:
- Detailed history taking including age ,parity, medical ,surgical history .
- Physical examination:
- General examination including the body mass index .
- Abdominal examination including presence of previous scars, uterine size , any tenderness and presence of palpable masses .
- Pelvic examination: including uterine size, any adnexal mass and tenderness .
- Preoperative investigation:
- A preoperative trans-vaginal ultra- sonography to assess the volume of the uterus, gross uterine pathology and any adnexal pathology.
- The preoperative laboratory investigation: hemoglobin percent and haematocrit value, blood grouping ,liver and kidney function tests.
Availability of blood was ensured for each patient before surgery.
Anaesthesia:
Standardized general anaesthetic technique consisting of induction agent, muscle-relaxant and inhalational agents with basic minimum monitoring after a detailed pre-anaesthetic check-up and adequate premedication advice.
Intraoperative :
- For vaginal cuff closure both in laparoscopic approach and vaginal route, the investigators will use the horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, and will continue toward the surgeon , using a continuous Vicryl suture .
- In the laparoscopic approach, needles will be introduced through one trocar and removed through the opposite trocars using a needle holders.
Postoperative care:
- The patient will receive IV fluids in the first 24hours (3litres).
- Oral clear fluid intake will be started 8 hours after the operation.
- Another dose of antibiotics will be received 6hrs after the operation with the same regimen used in induction.
- Postoperative analgesia will be received in the form of parental NSAIDs every 8hrs for 24hrs then on demand.
- The urinary catheter and the vaginal pack will be removed 24hrs after the operation , no drains will be left intraoperative.
- CBC will be done 24hrs after the operation.
- Histopathological examination of the specimen will be done.
- Precocious resumption of coital activity ,( all patients will be recommended to avoid vaginal intercourse for at least 2 months ) .
Follow Up:
- Transvaginal ultrasound will be done to all patients in the second day to Spot vaginal cuff hematoma if found .
- Women will be discharged on antibiotic ( third generation cephalosporins ) and analgesics ( NSAIDs ) and a follow-up visit will be scheduled after 7 days for a full examination to exclude vaginal cuff infection ( purulent drainage from the vaginal cuff on gross anatomic exam according to CDC ) or cuff hematoma (Any blood collection at the level of vaginal vault detected by transvaginal ultrasound).
- All women will be followed up after 3 months for the occurrence of vaginal cuff dehiscence (separation of a vaginal incision that was previously closed at time of initial hysterectomy) , at that time all women will undergo abdominal examination and bimanual pelvic examination for vaginal masses.
- All women will be asked for dyspareunia according to Marinoff scale: 0= no pain with intercourse .
- pain with intercourse that doesn't prevent the completion .
- pain with intercourse requiring interruption or discontinuance .
- pain with intercourse preventing any intercourse .
- Ethical Considerations:
- Patient information and informed consent:
Before being admitted to the clinical study, the patient must consent to participate after the nature, scope and possible consequences of the clinical study have been explained in a form understandable to her.
Protocol approval:
Before the beginning of the study and in accordance with the local regulation followed, the protocol and all the corresponding documents will be declared for Ethical and Research approval by the council of the OB/GYN department, Ain Shams University.
Assessment of the outcomes:
Primary outcomes:
- Vaginal cuff dehiscence: Any separation at the level of the vaginal vault.
Secondary outcomes:
- Vaginal cuff hematoma: Any blood collection at the level of vaginal vault detected by transvaginal ultrasound.
- Post operative pelvic infections: Any postoperative infection with signs and symptoms of vaginal cuff involvement including granulation formation .
- Operative time: Time spent in suturing the vaginal cuff transvaginally versus laparoscopically .
- Incidence of dyspareunia : according to Marinoff scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopical l cuff closure | Active comparator | Biological: laparoscopical l cuff closureneedle holder laparoscopic vaginal cuff closure |
| transvaginal cuff closure | Active comparator | Biological: laparoscopical l cuff closuretransvaginal cuff closure |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients candidate for total laparoscopic hysterectomy :
- Completion of the entire procedure by laparoscopic approach up to colpotomy.
- Benign conditions as indications for hysterectomy.
Key exclusion criteria (2 listed)
- 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.
- 4) Inability to express adequate informed consent to participate in the study.
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 |
|---|---|---|
| laparoscopical l cuff closureAlso: transvaginal cuff closureclosure of vaginal cuff following hysterectomy | Biological | laparoscopical l cuff closure, transvaginal cuff closure |
Primary outcome
1. number of cases ofVaginal cuff dehiscence
Time frame: 3 months
Any separation at the level of the vaginal vault.
2 secondary outcomes
number of cases with vaginal hematoma
Time frame: 3 months
number of cases with vaginal infection
Time frame: 3 months
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 30 Dec 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Vaginal Cuff Dehiscence
Recruiting
Comparison of Self-Locking Versus Traditional Sutures in Double-Layer Laparoscopic Vaginal Vault Closure After Hysterectomy (BI-SURE Trial)
Gynecologic Cancers, Vaginal Cuff Dehiscence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopical l cuff closure in people with Vaginal Cuff Dehiscence and Vaginal Hematoma, run by El-Galaa Military Medical Complex at 1 site in Egypt.
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 7 inclusion and 2 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 30 Dec 2021. 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 Egypt. 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?
1. number of cases ofVaginal cuff dehiscence (time frame: 3 months). 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 30 Dec 2021; AzTrials last refreshed its copy on 28 Oct 2026.