Reduction of postoperative adhesions with an auto-crosslinked hyaluronan gel in gynaecological laparoscopic surgery: a blinded, controlled, randomized, multicentre study.

BACKGROUND: Following myomectomy, postoperative adhesions occur in many patients with adverse effects on fertility. This study investigated the applicability, safety and efficacy of an auto-crosslinked hyaluronan gel in preventing adhesion formation after laparoscopic myomectomy. METHODS: Fifty-two patients aged 22-42 years, undergoing surgery at four centres, were randomly allocated to receive either the gel or no adhesion prevention. The incidence and severity of postoperative adhesions were assessed laparoscopically after 12-14 weeks in a blinded, scored fashion. The primary efficacy variable was the presence/absence of postoperative adhesions at second-look. RESULTS: A nonsignificantly higher proportion of patients receiving the gel were free from adhesions (13 of 21; 62%) compared with control patients (9 of 22; 41%), with a statistically significant difference between the severity of uterine adhesions at baseline and at second-look (0.3 +/- 0.9 versus 0.8 +/- 1.0, P < 0.05). In subjects undergoing myomectomy without concomitant surgery, the proportion of adhesion-free patients was 8 of 12 (67%) and 4 of 11 (36%) (not significant) in the gel and control groups, respectively, with a significant difference in the mean severity scores (P < 0.05). In subjects without uterine adhesions before myomectomy, 12 of 18 (67%) and 8 of 20 (40%) patients in the gel and control groups, respectively were adhesion-free (not significant), with a significant difference in the severity of uterine adhesions (P = 0.05). CONCLUSIONS: Our results suggest that the auto-crosslinked hyaluronan gel may have a favourable safety profile and efficacious antiadhesive action following laparoscopic myomectomy.

Sentinel Lymph Node (SLN) laparoscopic assessment early stage in endometrial cancer.

BACKGROUND: The aim of the study was to demonstrate the validity of sentinel lymph node (SLN) detection after injection of radioactive isotope and patent blue dye in patients affected by early stage endometrial cancer. The second purpose was to compare radioactive isotope and patent blue dye migration. METHODS: Between September 2000 and May 2001, 11 patients with endometrial cancer FIGO stage Ib (n=10) and IIa (n=1) underwent laparoscopic SLN detection during laparoscopic assisted vaginal hysterectomy with bilateral salpingo-oophorectomy and pelvic bilateral systematic lymphadenectomy. Radioactive isotope injection was performed 24 ours before surgery and blue dye injection was performed just before surgery in the cervix at 3, 6, 9 and 12 hours. A 350 mm laparoscopic gamma-scintiprobe MR 100 type 11, (99m)Tc setted (Pol.Hi.Tech.), was used intraoperatively for detecting SLN. RESULTS: Seventeen SLN were detected at lymphoscintigraphy (6 bilateral and 5 monolateral). At laparoscopic surgery the same locations were found belonging at internal iliac lymph nodes (the so called "Leveuf-Godard" area, lateral to the inferior vescical artery, ventral to the origin of uterine artery and medial or caudal to the external iliac vein). Fourteen SLN were negative at histological analysis and only 3 positive for micrometastasis (mean SLN sections = 60. All the other pelvic lymph nodes were negative at histological analysis. The same SLN locations detected with g-scintiprobe were observed during laparoscopy after patent blue dye injection. CONCLUSIONS: If the sensitivity of the assessment of SLN is confirmed to be 100%, this laparoscopic approach could change the management of early stage endometrial cancer. The clinical validity of this technique must be evaluated prospectively.

Pre-operative lymphatic mapping and intra-operative sentinel lymph node detection in early stage endometrial cancer.

Lymphatic mapping and sentinel lymph node (SLN) biopsy are becoming increasingly useful for the identification of tumour lymphatic spread in a wide variety of neoplasms, such as breast cancer and melanoma, reducing unnecessary radical lymph node resection. The aim of our study was to determine the feasibility of lymphatic mapping with both labelled colloid and patent blue violet in patients with early stage endometrial cancer. Sixteen consecutive patients with endometrial cancer, stage International Federation of Gynecology and Obstetrics (FIGO Ib), were included in the study. Lymphoscintigraphy and laparoscopically assisted intra-operative SLN detection were performed in all patients. In addition, to verify the prognostic role of this method, 12 of 16 patients were followed up for a period of at least 1 year. In 15 of 16 patients, 24 SLNs (all internal iliac lymph nodes) were detected at lymphoscintigraphy (six monolateral and nine bilateral). At histological analysis, three of the 24 were positive for micrometastases, whereas the remaining 21 were negative. No other surgically dissected lymph nodes presented metastases. At 1 year of follow-up, none of the 12 patients presented relapse of their disease. In conclusion, in endometrial cancer, both pre-operative lymphoscintigraphy and intra-operative gamma-probe detection of SLNs represent promising tools for the visualization of SLNs. The status of the latter may yield a correct representation of pelvic lymph node involvement, providing important information for further treatment.

Preliminary study of sentinel node identification with 99mTc colloid and blue dye in patients with endometrial cancer.

AIMS AND BACKGROUND: Intraoperative lymphatic mapping and sentinel node (SLN) biopsy have generated a tremendous amount of interest and are already established as part of the standard practice in the surgical management of breast cancer and melanoma. To reduce extensive radical procedures and decrease the morbidity in the treatment of gynecologic malignancies, much effort is being made to use less aggressive interventions. The purpose of our study was to determine the feasibility of SLN mapping in a group of patients with endometrial cancer at early stages. METHOD AND STUDY DESIGN: Between September 2000 and May 2001 11 patients with endometrial cancer FIGO stage Ib (n = 10) and IIa (n = 1) underwent laparoscopic SNL detection during laparoscopy-assisted vaginal hysterectomy with bilateral salpingo-oophorectomy and bilateral systematic pelvic lymphadenectomy. Radioactive isotope injection was performed 24 hours before surgery and blue dye injection was performed just before surgery in the cervix at 3,6, 9 and 12 hours. A 350 mm laparoscopic gamma scintyprobe MR 100 type 11, 99mTc settled (Pol Hi Tech), was used intraoperatively for SLN detection. RESULTS: Seventeen (17) SLNs were detected with lymphoscintigraphy (six bilateral and five unilateral). At laparoscopic surgery we found the same locations belonging at internal iliac lymph nodes (the so-called Lebeuf-Godard area, lateral to the inferior vesical artery, ventral to the origin of the uterine artery and medial or caudal to the external iliac vein). Fourteen (14) SLNs were negative on histological analysis and three were positive for micrometastases (mean SLN sections = 60). All other pelvic lymph nodes were negative at histological analysis. The same SLN locations detected with the gamma scintyprobe were observed at laparoscopy after patent blue dye injection. CONCLUSIONS: Our preliminary data suggest that combined 99mTc-labeled colloid and vital blue-dye techniques are feasible for SLA detection in endometrial cancer; they represent a very promising tool to transform the management of early-stage endometrial cancer. The clinical validity of this combined technique should be evaluated prospectively.

Laparoscopic uterine suspension using three-stitch technique.

We conducted a prospective, longitudinal study to assess the efficacy of a new laparoscopic hysteropexy technique in alleviating pelvic pain. Subjects were 50 women of reproductive age with chronic pelvic pain or dyspareunia in whom the only clinical finding was uterine retroversion who underwent laparoscopic uterine suspension using three-stitch technique. There were no intraoperative complications. The only postoperative complication was abdominal pain in one woman. The technique was effective in relieving symptoms in these patients. Of the 22 women who had associated infertility for longer than 3 years, 10 became pregnant within 1 year after surgery. This benefit, however, is likely due to couples' improved sex life rather than change in surgical axis of the uterus.

Weekly cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer: a well-tolerated alternative.

To assess the efficacy and the compliance of weekly cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer, 23 patients, FIGO stage IB-IIA > 4 cm-IIB, were recruited. Treatment consisted of four weekly courses of cisplatin (1.5 mg/kg): 91% of the patients received the planned therapy without dose reduction or delay. Toxicity was mild: delayed emesis was the most common side effect. Overall clinical response rate was 85% with a complete response in 28%. Nineteen patients underwent surgery without any undue increase in morbidity. Histologic analysis of surgical specimens revealed a complete response in 25% of stage IB-IIA patients; in only one case of stage IIB, was residual parametrial involvement present. In conclusion, weekly cisplatin is highly effective, with lower cost and less toxicity compared to other neoadjuvant chemotherapy regimens.

Use of an endolaparoscopic probe in conservative management of Fallopian pregnancy.

The incidence of extrauterine pregnancy has shown an increasing trend, exceeding one out of every 100 term pregnancies. This has resulted in the development of more and more conservative surgical treatments in order to retain the fertility of women. The use of operative laparoscopy has led to progress being made in this direction, due to reduced tissue trauma and a reduction in the number of peritoneal adhesions. Tubal isthmic pregnancies tend to cause an irregular increase in the size of the whole tube, which causes problems for pinpointing the exact site of the ectopic implantation. It is often necessary to make a longitudinal incision in the tubal wall to identify the chorionic tissue and remove it completely. In an attempt to avoid this unnecessarily extensive surgery, we used an echographic sector probe under laparoscopic control to locate the exact area of the ectopic implantation. We found it was possible to remove the villous tissue through a very short and precise cut in the tubal wall which facilitated the drainage of the lumen and reduced the bleeding normally associated with more extensive tubal surgery. Hysterosalpingographic follow-up studies after 2 months showed good tubal recanalization.

Vaginal treatment with a prostaglandin F2 alpha derivative (alfaprostol) for inducing labor in pregnancy at term.

The effectiveness and acceptability of Alfaprostol (an analog of PGF2 alpha) in inducing labor were assessed in 20 pregnant women at term. All subjects had no spontaneous uterine activity before treatment and the mean (M +/- SE) Bishop score was 2.45 +/- 0.21. The drug was administered by vaginal route at the dose of 10 mg every 3 hours. Regular uterine contractions appeared in all patients and delivery occurred in 85% of the patients after a mean time of 9h50min +/- 0h55min following the start of treatment. The mean dose of Alfaprostol utilized to achieve delivery was 29.4 +/- 2.0 mg. No major side effects were noted in the mothers and their fetuses at any time during treatment. Two patients exhibited vomiting. The Apgar score of all newborns at birth was 8 or more. These results suggest the usefulness of Alfaprostol to induce labor in pregnant women at term, as it has oxytocic activity without adverse effects on either the mother or the fetus.

[Use of a new synthetic prostaglandin (sulprostone) in various obstetrical conditions]. / L'uso di una nuova prostaglandina di sintesi (sulprostone) in diverse condizioni ostetriche.

PIP: A new prostaglandin E2 (PGE2) derivative, the 16 phenoxy-omega-tetranor PGE2 methylsulphonylamide of Sulprostone, was administered to 56 patients to induce preoperative cervix dilatation (1st trimester) and termination of pregnancy for missed abortion (1st and 2nd trimester), or fetal death (3rd trimester). Different dose schedules have been administered intramuscularly. Hourly side effects were recorded. Among 46 patients, Sulprostone induced cervical dilatation (8 mm or more) in 36 subjects. In the others, the cervix dilated at least 6 mm. With regard to the termination of pregnancy, uterine contractions and discharge occurred within a short time. The incidence of side effects was minimal. Our study seems to indicate the usefulness, efficacy, and acceptability of Sulprostone in the management of different obstetric conditions. (author's modified)^ieng