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Laparoscopic uterine removal: comparison between three abdominal incisions' technique or single umbilical incision surgery

Laparoscopic Hysterectomy: comparative study between Multiport and Single Port Laparoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6hhxzv
Enrollment
Unknown
Registered
2016-08-08
Start date
2013-08-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the genitourinary system, excessive, frequent and irregular menstruation, leiomyoma of uterus, polyp of corpus uteri, endometriosis of uterus

Interventions

Two groups were studied: 21 patients were submitted to laparoscopic hysterectomy with three punctions and 21 patients were submitted to laparoscopic hysterectomy with single umbilical incision. Surge
Procedure/surgery

Sponsors

Faculdade de Medicina da USP
Lead Sponsor
Faculdade de Medicina da USP
Collaborator

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: age between 35 and 65 years old; benign uterine disease with indication of hysterectomy; no reproductive interest; uterine volume until 600cm3

Exclusion criteria

Exclusion criteria: coagulopathy; chronic use of anti-inflammatory drugs; suspicion of uterine malignancy; contra-indication of general anesthesia or pneumoperitonio; genital prolapse; incapacity of read or understand the informed consent

Design outcomes

Primary

MeasureTime frame
To Compare the results of laparoscopic hysterectomy with multiple functions (M-TLH) with single-port laparoscopic hysterectomy SP-TLH). ;The operative time was defined as the interval from the incision of the abdominal skin until the placement of the last stitch on the abdominal skin, in both groups.;Blood loss was analized accessing the hemoglobin variation (immediately before and after surgery on the 1st, 2nd and 6th postoperative days) and total blood volume aspirated during the surgery.;The surgical complications were divided in immediate, that occurred from the beginning of the surgery until the sixth postoperative day, and late complications that occurred from this period up to 12 months after the procedure.;Inflammatory responses were evaluated via the venous peripheral blood levels of CRP, IL-6, IL-10, TNF, VEGF and leukogram results (immediately before and after surgery on the 1st, 2nd and 6th postoperative days).;Postoperative pain intensity was estimated using a visual analog scale (VAS)12 on the 1st, 2nd and 6th postoperative days.;Patient satisfaction were analyzed using Short Form 36 Health Survey before and 12 months after surgery.;We hope to find longer surgical time, less postoperative pain, blood loss, complications, inflammatory response in single-port group. ;The operative time was significantly longer in the SP-TLH group than in the M-TLH group. In terms of blood loss, inflammatory responses, pain, complications and quality of life both techniques were similar. We observed three cases of umbilical hernia in single-port group, 12 months after surgery.

Secondary

MeasureTime frame
Long term complications of the surgery. We defined as long term, 6 months after the surgery.;We noticed 3 cases of umbilical hernia in the HLU group. In the HLM group, there was none.

Countries

Brazil

Contacts

Public ContactRenata Tormena

Divisão de Clínica Ginecológica do Hospital das Clínicas da Universidade de São Paulo da Faculdade De Medicina Da Universidade de São Paulo

r.tormena@uol.com.br+55 (11) 999320319

Outcome results

None listed

Source: REBEC (via WHO ICTRP)