A prospective study of conization of the cervix in the management of cervical intraepithelial glandular neoplasia (CIGN)--a preliminary report.

OBJECTIVE

To assess the efficacy of cervical conization as primary management of cervical intraepithelial glandular neoplasia (CIGN).

DESIGN

A multicentre prospective cohort study.

SETTING

CRC Clinical Trials Unit, Birmingham.

SUBJECTS

84 women registered with the Unit between May 1986 and January 1989. After excluding 33 women, 51 who had been managed in accordance with the described protocol and had the presence of CIGN confirmed by central review of diagnostic histopathological material were included in the study. INTERVENTION/PROTOCOL: Women with CIGN diagnosed on a cervical cone specimen were managed in accordance with a specific protocol: (a) women with negative cone margins were managed conservatively and followed up with regular cervical cytological and colposcopic examinations; (b) women with involved cone margins were managed by hysterectomy.

MAIN OUTCOME MEASURES

Presence or absence of CIGN at cone margins, results of cervical cytological examinations following conization, results of histopathological assessment of any surgical specimens taken after initial cone biopsy.

RESULTS

Of the 51 women with confirmed CIGN, managed by conization, 14 (27%) were aged 30 or less and 15 (29%) were nulliparous. Thirty five women who had a cone biopsy showing margins free of CIGN have been managed by conization alone. After a median follow-up period of 12 months there is no apparent residual CIGN or invasive disease in this group. Thirteen women have had further surgical procedures (according to protocol) and two have had a hysterectomy for benign gynaecological disorders. Eight further procedures were carried out because the original cone biopsy had margins involved with CIGN, and only one of them was found to have residual CIGN. The other five procedures were carried out solely because of abnormal cytology, only one of them had a diagnosis of CIN 1. A total of 10 women had cytological abnormality following cone biopsy, one had CIGN, one had CIN 1 and a third had CIN 3.

CONCLUSIONS

Our preliminary data suggests that when a diagnosis of CIGN is made upon a cone biopsy, further surgery is unnecessary in those women in whom the margins of the cone specimen are free of disease. Cytological and colposcopic follow up, including cytological sampling of the endocervical canal, is recommended for these women.