Less surgery may be safer for early cervical cancer patients
NCT ID NCT01639820
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 267 women with early-stage cervical cancer to compare two surgical approaches: removing all pelvic lymph nodes versus removing only the sentinel (first) lymph node. The goal was to see which method causes fewer complications within 6 months after surgery. Researchers also tracked quality of life, costs, and cancer recurrence to find the best approach.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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267 people
The number who actually took part.
- Start date
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Jan 2009
- Finished
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Dec 2012
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women 18 years of age or older, * Absence of contraindication to laparoscopy, * Uterine cervical carcinoma (every histological type except neuroendocrine), * Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter), * Negative pregnancy test for women able to procreate, * Having the French National Social Security * Signed informed consent Exclusion Criteria: * Neuroendocrine carcinoma, * In situ carcinoma or stage IA1 without LVSI, * Maximal tumoral diameter measured by MRI more than 4 cm, * Stage IB1 by "down-staging", * Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) , * Presence of distant metastases, * Progression of the cervical cancer or recurrence, * History of pelvic lymphadenectomy, * Other cancer diagnosed during the course of treatment, * Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide, * History of severe allergy (history of Quincke's edema, anaphylactic shock), * Patient who does not understand, speak or write the French language, * Pregnant woman
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service de Gynécologie, Hôpital Femme Mère Enfant
Bron, 69677, France
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Other studies related to the condition(s) this trial covers.