Laparoscopic Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer (LAP-OPEN)
Radical Laparoscopic-assisted Hysterectomy Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer: A Comparative Study
The study aims to compare laparoscopic-assisted radical hysterectomy with open radical hysterectomy in women with early-stage cervical cancer. A total of 60 patients diagnosed with FIGO stage IA1, IA2, and IB1 cervical cancer were enrolled and randomly assigned into two equal groups: laparoscopic surgery and open surgery. All patients underwent total hysterectomy, bilateral adnexectomy, and pelvic lymph node dissection.
Perioperative outcomes were evaluated, including operative time, blood loss, complications, and hospital stay, as well as long-term oncological outcomes such as recurrence, recurrence-free survival, and overall survival. Patients were followed for up to three years postoperatively. The findings of this study aim to assess the safety, feasibility, and clinical effectiveness of laparoscopic-assisted surgery compared with the conventional open approach in the management of early-stage cervical cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Cervical cancer remains one of the leading causes of cancer-related morbidity and mortality among women worldwide. Radical hysterectomy is the standard surgical treatment for early-stage cervical cancer. Traditionally, this procedure has been performed through an open abdominal approach; however, minimally invasive techniques, including laparoscopic-assisted radical hysterectomy, have gained increasing attention due to their potential advantages in reducing surgical trauma and improving perioperative recovery.
This study was conducted to compare the clinical and oncological outcomes of laparoscopic-assisted radical hysterectomy versus open radical hysterectomy in patients with early-stage cervical cancer. A total of 60 patients diagnosed with FIGO stage IA1, IA2, and IB1 cervical cancer were included. Participants were admitted to Zagazig University Hospitals between March 2021 and January 2024.
Eligible patients were randomly assigned into two groups: a laparoscopic surgery group and an open surgery group. All patients underwent total hysterectomy, bilateral adnexectomy, and pelvic lymph node dissection. In the laparoscopic group, vaginal stump closure was performed using an endoscopic stapler, whereas in the open group, closure was performed using conventional surgical techniques.
Primary outcomes included perioperative parameters such as operative time, intraoperative blood loss, blood transfusion, complications, hospital stay, and time to removal of urinary catheter and drainage tube. Secondary outcomes included long-term oncological outcomes such as recurrence rate, recurrence-free survival, and overall survival. Patients were followed for up to three years postoperatively.
The study aimed to determine whether laparoscopic-assisted radical hysterectomy provides comparable safety and oncological outcomes to open surgery while offering potential advantages in perioperative recovery. This study was registered retrospectively, as patient enrollment had been completed prior to trial registration, in accordance with journal requirements and to ensure transparency in reporting.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Sharqia Province
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Zagazig, Sharqia Province, Egypt
- Zagazig University Hospitals
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- FIGO stage IA1, IA2, IB1
- patients with a tumor size < 2 cm by MRI or pathological assessment after conization
- tumours with histopathological subtypes: squamous cell carcinoma, adenocarcinoma and adeno-squamous carcinoma (
- patients with adequate; hematopoietic, renal and liver functions:
- patients with BMI < 35 (
- patients with age range 38 - 65 years old.
Exclusion Criteria:
- patients with mental, heart, bladder, liver, or kidney illness
- patients who had received pre-operative chemotherapy or radiotherapy pregnant patients
- patients with incomplete data or lost follow-up
- patients with radiological evidence of invasion of the outer 1/3 of the cervical stroma or the lower uterine segment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Laparoscopic Radical Hysterectomy
In this study, participants underwent radical hysterectomy with bilateral adnexectomy and lymph node dissection using a laparoscopic approach, and vaginal stump closure using an endoscopic stapler was performed.
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In this procedure, a minimally invasive laparoscopic-assisted radical hysterectomy is performed, including dissection of the pelvic lymph nodes and closure of the vaginal stump with an endoscopic stapler.
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Aktiv komparator: Open Radical Hysterectomy
Under conventional surgical techniques in this group , participants underwent open abdominal radical hysterectomy with bilateral adnexectomy and dissection of pelvic lymph nodes.
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A standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Operative Time
Tidsramme: Intraoperative period (day of surgery)
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The surgery duration will be measured in minutes from skin incision to closure.
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Intraoperative period (day of surgery)
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Intraoperative Blood Loss volume
Tidsramme: Intraoperative period
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Assessment of volume of intraoperative blood loss (mL): Estimated blood loss volume measured in millilitres during surgery.
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Intraoperative period
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Length of Hospital Stay
Tidsramme: Up to 30 days post-surgery
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Duration of hospital stay measured in days from surgery to discharge
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Up to 30 days post-surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recurrence Rate
Tidsramme: Up to 3 years postoperatively
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Assessment of cancer recurrence following surgical intervention during the follow-up period.
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Up to 3 years postoperatively
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Ola A Harb, Professor, Zagazig University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Livmorsykdommer
- Kjønnssykdommer, kvinner
- Genitale neoplasmer, kvinnelige
- Livmor livmorhalssykdommer
- Uterine neoplasmer
- Uterine cervikale neoplasmer
Andre studie-ID-numre
- LAPvsOPEN-RH-Study
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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