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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 .
All the women will subject to:
Preoperative Assessment including:
Detailed history taking including age ,parity, medical ,surgical history .
Physical examination:
Preoperative investigation:
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 :
Postoperative care:
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 .
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:
1. 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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopical l cuff closure | Active Comparator | needle holder laparoscopic vaginal cuff closure |
|
| transvaginal cuff closure | Active Comparator | transvaginal cuff closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopical l cuff closure | Biological | closure of vaginal cuff following hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. number of cases ofVaginal cuff dehiscence | Any separation at the level of the vaginal vault. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of cases with vaginal hematoma | ultrasound finding | 3 months |
| number of cases with vaginal infection | purulent vaginal discharge |
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Inclusion Criteria:
Patients candidate for total laparoscopic hysterectomy :
Completion of the entire procedure by laparoscopic approach up to colpotomy.
Benign conditions as indications for hysterectomy.
Exclusion Criteria:
- 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Cairo | 11111 | Egypt |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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neither the paticipant nor the investigator knew type of vaginal cuff closure
| 3 months |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |